Company
Portfolio Data
Back to Company SearchBEKEN BIO, INC.
UEI: LJJ9XNCRE9L7
Number of Employees: 3
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2024
1
Phase I Awards
1
Phase II Awards
100%
Conversion Rate
$275,000
Phase I Dollars
$1,249,464
Phase II Dollars
$1,524,464
Total Awarded
Awards
SBIR Phase II: Liquid Biopsy Diagnostic Targeting Novel Extracellular Vesicle Biomarkers
Amount: $1,249,464 Topic: BM
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve tools available for cancer detection and diagnoses through a minimally invasive technique. Through improving on standard techniques and utilizing quantifiable biomarker readouts, this project can deliver faster diagnoses, earlier treatment decisions, and more consistent risk stratification. This technology is designed to scale to other hard-to-detect cancers, broadening public health benefit and supporting a durable commercial pathway from laboratory testing to future distributed diagnostics. This Small Business Innovation Research (SBIR) Phase II project advances and validates a tool that measures cancer signals carried by extracellular vesicles (EVs), tiny particles released by tumor cells. These vesicles carry proteins and genetic material that mirror tumor activity, allowing a standard blood sample to capture disease signals without imaging or surgery. EVs appear in the bloodstream earlier and in greater numbers than circulating tumor cells and have been detected at tumor volumes near 1 cm3, supporting detection before symptoms arise. This research will conduct a prospective, blinded study of roughly 300 patients undergoing surgery, comparing test results with the final surgical diagnosis as the reference standard. The study will deliver test sensitivity and specificity and assess performance across age groups and common comorbidities to ensure broad clinical utility. The work will also demonstrate reproducibility and establish rigorous quality controls needed for clinical laboratory use. Analytical testing will confirm stability and precision throughout testing. Finally, the project will use a 3D cell culture discovery system a novel technology to identify additional EV biomarkers. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
Tagged as:
SBIR
Phase II
2026
NSF
SBIR Phase I: Liquid Biopsy Diagnostic for Early Detection of Ovarian Cancer Targeting Novel Extracellular Vesicle Biomarkers
Amount: $275,000 Topic: BM
The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project focuses on advancing a novel ovarian cancer (OC) diagnostic to enhance patient outcomes significantly. This initiative introduces a pioneering method for identifying biomarkers within extracellular vesicles (EVs), early markers specific to cancer circulating in the bloodstream. By targeting cancer EVs in a minimally invasive blood test, the project aims for unprecedented sensitivity and specificity in early detection. Success in this endeavor could pave the way for adapting the approach to develop diagnostics for other cancer types. The global market for OC diagnostics, currently valued at $1.3 billion and growing at an annual rate of 7%, reflects increasing incidence rates in younger populations and a growing emphasis on early detection strategies. A successful outcome from this project would position any resulting products favorably in the broader landscape of cancer detection technologies. This Small Business Innovation Research (SBIR) Phase I project aims to develop a highly sensitive, minimally invasive laboratory test to detect early-stage ovarian cancers (OC) by assaying relevant biomarkers on circulating extracellular vesicles (EVs) in patient plasma. EVs provide significant advantages in sensitivity and patient outcomes over tests using circulating tumor cells or cell-free tumor DNA, as they are secreted by living cancer cells within the primary tumor. This project will utilize a novel technology to identify key proteins in EVs from various OC subtypes, engineering an assay to differentiate between patients with malignant tumors and those without cancer with high specificity. The second objective is to employ a machine learning tool to perform diagnostic classification, providing actionable information to clinicians regarding the presence of a tumor. Successful completion of these objectives will facilitate the development and validation of scalable workflows for the diagnostic assay during Phase II, with the goal of having a laboratory-developed test ready for commercialization by the end of Phase II. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
Tagged as:
SBIR
Phase I
2024
NSF